COVID Feel Good - an easy self-help virtual reality protocol to overcome the psychological burden of coronavirus
| ISRCTN | ISRCTN63887521 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63887521 |
| Secondary identifying numbers | 2020_06_16_09 |
- Submission date
- 02/07/2021
- Registration date
- 06/08/2021
- Last edited
- 18/09/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Living during the COVID-19 pandemic means experiencing not only a global health emergency but also extreme psychological stress which could cause potential emotional side effects such as sadness, grief, irritability, and mood swings. Crucially, lockdown and related social restrictive measures isolate people who become the first and the only ones in charge of their own mental health: people are left alone facing a novel and potentially lethal situation, and, at the same time, they need to develop adaptive strategies to face it, at home. Because of this, easy-to-use, inexpensive, and scientifically validated self-help solutions aiming to reduce the psychological burden of coronavirus are extremely necessary.
This study aims to test the efficacy of “COVID Feel Good” a self-help Virtual Reality (VR)-based program to help individuals to cope with the psychological burden related to the COVID-19 pandemic and restrictive social distancing measures.
Who can participate?
Adults who have experienced at least two months of social distancing measures (e.g. staying at least 6 feet from other people who are not from your household, wearing masks) who are able to access the internet using a smartphone with Internet access and have normal, or corrected-to-normal, vision.
What does the study involve?
Participants will be allocated to one of two groups, with an equal chance of being in either group (like tossing a coin), to receive treatment with the “COVID Feel Good” a self-help Virtual Reality (VR)-based program or no treatment and to be put on a waiting list for the VR program. The program involves watching a 10 min three hundred sixty–degree (360°) video, titled “The Secret Garden” at least once a day for a week. Each day, after the VR protocol, participants are invited to perform a series of social exercises with targeted goals for each day of the week. Participant levels of depressive and anxiety symptoms, general distress, perceived levels of stress, hopelessness, perceived interpersonal closeness with the social world, and fear of COVID-19 will be assessed at the beginning of the study, at the end of the VR program (after 7 days), and at a 2-week follow-up (21 days).
What are the possible benefits and risks of participating?
it is hoped that the weekly VR-based self-help program will be associated with a reduction of depressive and anxiety symptoms, general distress, perceived levels of stress, hopelessness, and fear of COVID-19, with an increase in perceived interpersonal closeness with the social world at the end of treatment compared with both responses from participants in the waiting list condition and baseline responses at the start of the study. It is also predicted that treatment benefits will be maintained at 2-weeks follow-up.
There are no significant risks associated with participating in the study. Participants will be adequately informed about the fact that VR can cause fatigue or slight symptoms of cybersickness (e.g. dizziness), and if these occur, participants are invited to stop the session. Symptoms of cybersickness should subside within a few minutes after terminating exposure to VR.
Where is the study run from?
Istituto Auxologico Italiano (Italy) and centers in Australia, Germany, Italy, Japan, Romania, Spain, and the United States of America
When is the study starting and how long is it expected to run for?
From April 2020 to December 2021
Who is funding the study?
Istituto Auxologico Italiano (Italy)
Who is the main contact?
Prof Giuseppe Riva
bepperiva@auxologico.it
Contact information
Scientific
Applied Technology for Neuropsychology Lab
Istituto Auxologico Italiano
Via Magnasco 2
Milano
20146
Italy
 ORCID ID |
0000-0003-3657-106X |
|---|---|
| Phone | +390272343734 |
| bepperiva@auxologico.it |
Study information
| Study design | Multi-center interventional randomized wait list-controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | An easy self-help virtual reality protocol to overcome the psychological burden of coronavirus (COVID Feel Good) |
| Study acronym | COVID Feel Good |
| Study hypothesis | 1. The use of the weekly VR self-help protocol will decrease depressive and anxiety symptoms, general distress, perceived levels of stress, hopelessness (primary outcome measures) 2. The use of the weekly VR self-help protocol will increase the perceived interpersonal closeness with the social world and will decrease the fear of COVID-19 (secondary outcome measures) |
| Ethics approval(s) | Approved 16/06/2020, Istituto Auxologico Italiano Comitato Etico (Via L. Ariosto 13, 20145 Milano, Italy; +39 (02) 619112237; comitato.etico@auxologico.it), ref: 2020_06_16_09 |
| Condition | Psychological burden related to the COVID-19 pandemic and restrictive social distancing measures |
| Intervention | COVID Feel Good is a self-help Virtual Reality (VR)-based protocol aimed at helping individuals to overcome the psychological burden related to the COVID-19 pandemic and restrictive social distancing measures. Participants will be randomly allocated (1:1) to either the “COVID Feel Good” a self-help Virtual Reality (VR)-based program group or waiting list control group. Randomization will be done using a computer-generated, block randomization sequence (R psych library, block.random function). Participants are invited to use the VR program at least once a day for 7 days. Participants will receive six modules consisting of two integrated parts: the first part consists of a 10 min 360° VR video entitled “Secret Garden” and the second part includes a series of social exercises, with a specific goal for each day of the week. The immersive experience is accompanied by a relaxation induction narrative structured following the principles of Compassion Focused Therapy. At the end of the VR exposure, participants were invited to perform a series of social tasks related to personal identity and interpersonal relationships. The tasks have the following general aims: 1. Helping participants to pay attention and recognize their emotional discomfort 2. Supporting participants to reinforce their coping skills 3. Helping participants to monitor themselves and protect self-esteem 4. Support participants in finding a personal meaning even in difficult times |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Depression, anxiety, and stress symptoms measured using the Depression Anxiety Stress Scale (DASS-21) at baseline, 7, and 21 days 2. Perceived stress measured using the 10-item Perceived Stress Scale (PSS) at baseline, 7, and 21 days 3. Pessimistic thoughts or negative attitude towards the future measured using the Beck Hopelessness Scale (BHS) self-report questionnaire at baseline, 7, and 21 days |
| Secondary outcome measures | 1. Social connectedness measured using the Social Connectedness Scale (SCS) self-report questionnaire at baseline, 7, and 21 days 2. Fear experienced during the COVID-19 pandemic measured using the Fear of Coronavirus (FCOR) scale at baseline, 7, and 21 days |
| Overall study start date | 01/04/2020 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 54 participants for each center. 324 total participants. |
| Total final enrolment | 40 |
| Participant inclusion criteria | 1. Aged ≥18 years 2. Fluent in the language of the country where they are enrolled 3. Has experienced at ≥2 months of the social distancing measures (such as wearing masks and staying ≥6 feet from other people who are not from their household) implemented by the country where they reside 4. Has a partner who is available and agrees to participate in the relational component of the treatment 5. Has a smartphone with internet access 6. Normal or corrected-to-normal vision |
| Participant exclusion criteria | 1. Diagnosis of major mental disorder 2. Lack of stereoscopic vision or a balance/vestibular problem that would disrupt the VR experience |
| Recruitment start date | 30/06/2020 |
| Recruitment end date | 01/10/2021 |
Locations
Countries of recruitment
- Australia
- Germany
- Italy
- Japan
- Romania
- Spain
- United States of America
Study participating centres
Via Magnasco 2
Milan
20146
Italy
Gottingen
37073
Germany
College of Behavioral, Social and Health Sciences
418 Daniel Hall
Delta Epsilon Ct
Clemson, SC
29631
United States of America
Tsukuba-shi
Ibaraki
305-8577
Japan
Barcelona
08007
Spain
Timisoara
300223
Romania
Hawthorn VIC
3122
Australia
Sponsor information
Hospital/treatment centre
Applied Technology for Neuropsychology Lab
Via Magnasco 2
Milan
20146
Italy
| Phone | +390272343734 |
|---|---|
| bepperiva@auxologico.it | |
| Website | https://www.auxologico.it/ |
"ROR" |
https://ror.org/033qpss18 |
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Auxologico
- Location
- Italy
Results and Publications
| Intention to publish date | 31/12/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact journal. The study protocol can be found at www.covidfeelgood.com |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Preprint results | 14/09/2021 | 20/12/2021 | No | No | |
| Results article | 02/08/2021 | 20/12/2021 | Yes | No | |
| Protocol article | 23/09/2020 | 12/08/2022 | Yes | No | |
| Results article | Results for German sites | 07/04/2022 | 12/08/2022 | Yes | No |
| Results article | Results for other European sites | 06/04/2023 | 14/04/2023 | Yes | No |
| Results article | 02/03/2023 | 18/09/2024 | Yes | No |
Editorial Notes
18/09/2024: Publication reference added.
14/04/2023: Publication reference added.
12/08/2022: Publication references added.
20/12/2021: The following changes have been made:
1. Publication reference added.
2. Preprint reference added.
3. The total final enrolment number has been added.
06/07/2021: Trial’s existence confirmed by the Ethical Committee of the Italian Auxological Institute.
